>> what you suggest is maybe more of an opportunity that's presented to people to do it rather than absolutely requiring >> also the office on aging because i would see in local communities, senator isakson, something that our committee has jurisdiction over are the office on aging. that's where so many of the old-timers often go for advice and counsel and information and so on. so let's get it quick and take it back up, okay? >> i appreciate the consideration. >> you told me you had an amendment that was -- you're

ready with your amendment? >> yes, sir. >> why don't you let us know which one it is. i'll distribute it. >> number one, sir. >> it's roberts number one? >> yeah, roberts number one. it's the one that you were going to take, you can just take it right now and you won't have to listen to me. >> is this in alphabetical order? >> page 20. >> this just says that cer can't be used exclusively for cost containment, et cetera, et cetera. if you wish, mr. chairman, i can begin and just -- >> yes, please do.

>> first, let me say that i don't know whose glasses these are, but they were lying down right there, and it looks to me like they would be a pair of women's glasses. i don't know whether they belong to somebody on that side. if they do, i'm not sure i could -- i want to give them the glasses. >> are they rose colored glasses? >> no, they're more like cbo glasses. >> rather opaque then, i presume. >> they are sort of bent up and they are -- but at any rate, i don't know whose glasses these are. it might belong to some camera person or whatever. and so i'm going to -- i can't hand it to anybody. i'm just going to leave them right here and proceed. >> thank you, senator.

whoever these are, you can see your way clear to support my amendment, that would be great. this amendment in my view protects patient choice and physician independence in making treatment decisions when, as we all know, we all support when a loved one gets sick or when we get sick. you want to be sure that you and your doctor are in charge of making decisions and not somebody else here in washington. or somebody else in some regional office. the amendment is identical to senator kyl's. stick with me. the preserving access to targeted individualized and effective new treatments and services act. now the reason that all that was stuck together is because, as you know, everything has to be an acronym in washington and that is called the p.a.t.i.e.n.t.s. bill. so after that explanation, the bill is endorsed by the american

medical association, and i am an original co-sponsor. it ensures that patients and doctors remain in charge of making treatment decisions by prohibiting the federal government from using the results of comparative effectiveness research, i.e., cer, to deny coverage under medicare or any other federal health program. in addition, it requires that cer conducted account for differences in the treatment responses and preferences of individual patients. these prohibitions are required because current law does not prohibit the government from using the $1.1 billion awarded to cer in the stimulus package for cost containment and to achieve cost savings. along with other goals. neither do the cer provisions in the bill before us today.

now we have all heard the horror stories of the united kingdom's national institute for health and clinical excellence. the acronym for that is n.i.c.e., and it's not very nice. delaying or denying access to cancer drugs and requiring seniors to go blind in one eye before approving treatment to access for macular degeneration, this is a real thing, it actually happens. we need this, it seems to me, to safeguard, to guarantee that this scenario will not happen in american medicine. i want to make it very clear this amendment does not prohibit cer. would never do that. i would never stand against medical innovation and advancement. we need cer. it does not interfere with the fda's ability to rule a medical treatment to be unsafe. i would never prevent. i don't think any member here would prevent he fda from fulfilling its mission of ensuring the safety of our medical products. it simply prohibits the federal

government from rationing health care based on this research. so it is to protect patients and to protect seniors. i would ask that people would support this amendment. i might add something here from personal experience. and i apologize for going on. i said before that i've had the privilege of public service for a long time. and i've said before that health care seems to be -- i don't know how it ends up under my jurisdiction. at least in terms of a committee or working for a previous member or wherever in my career. but that's been the case, and i've also expressed considerable frustration and angst dating clear back as i indicated to the chairman to joe kalifano and h.e.w. and h2 s, cms.

and i do have a little blood pressure. i have not been down to the agency recently. i would like to pay a visit, just indicate to them that i am -- i'm not exactly a total critic of what they do because they do have a very important job. but i can remember that we were in the midst about two or three years ago of several big time problems when we were trying to cut costs in health care. and i know that there's a lot of concern about greed and sour apples in the barrel and a lot of things that doctors may or may not do to make up for the lack of what they think is a proper reimbursement that should not be done. having said that, there was almost a revolution out there. the rural health care delivery system. tom arkadose is the co-chair of

the world health care coalition. i'm the other co-chair. i thank him for his contribution. and the one that really got me was this competitive bidding business with home health care. and i know this is sort of -- this is not directly on the subject, but it is. because one of the first regions was kansas city. in kansas city, that region included parts of missouri, parts of kansas that were not metropolitan areas by any means. it was supposed to be a metropolitan area. there were 428 home health care entities or businesses in this region in kansas. of the 428, i know at least two-thirds never even knew that they were in a competitive bidding process. didn't even know that that directive had come down and that they had "x" number of days to respond. but i did hear from some of the

bigger ones who said, whoa, wait a minute. this is not the way to do business. we can't do this. and so there was a lot of back and forth on that. finally, cms came down and recognized 24 in the bidding process. that were eligible for medicare. my question is if you have 428 people involved in home health care you recognize 24 eligible for medicare, what happens to the other 404? and that's where we were. so if you have an elderly person who relies on home health care and, number one, they didn't even know about it but once they did they were trying to catch up and to catch up was impossible because the 1-800 number was always busy. when it wasn't, when someone couldn't answer the question. so it was just a real problem with 404 of these entities out there that couldn't get medicare anymore by this edict that came down from cms. so i wasn't happy with that. about that time they had

nominated a gentleman by the name of kerry wiens to be the director of cms. i thought i'll take the bull by the horns and put a hold on him and made it public and so he naturally came in to see me. he was a nice fellow. he's from new mexico. he went to harvard but couldn't help that. and so we basically sat down and visited about it. and i prepared him a list of five questions that i had received primarily from doctors and hospital administrators and home health care people, clinical labs, pharmacists, et cetera. mainly on reimbursement and basically on all the regulations. he thanked me for it and said he'd get back to me immediately. he sent me back a five-page single spaced response that, quite frankly, i thought was cms gobbledy gook. i called him back and said i

can't understand this. nobody on my staff can understand it. you can understand why a senator wouldn't understand it, but not staff. so he came back and looked at it and said you're right. i signed this letter or somebody signed it and i can't read it either. and that's the signal right there i'm trying to get and the point i'm trying to make of what happens here when we turn things over to people. and then they are not even aware of what happens. so he sent back about a two-page later that made a lot of sense and promised he'd watch carefully for these reglaer to overkills and things driving our people nuts out there. and so i voted yes and hoped for the best with cms. i saw him later on an airplane flight. he had a ball cap. i didn't recognize him. i said for goodness sakes, kerry. then i thought to myself, am i going to have to sit on the airplane and talk about cms this whole flight. he probably thought the same thing. and the problem was that

everything that he promised in those five different areas, nothing happened except the things we didn't want to happen. and i told him that. i said you promised me. he even got on the telephone and i recommended five people for him to call. he sat there for two hours in my office and talked to people that were on the receiving end of this regulatory overkill. n yet we had the same problems. so it seems to me if we're going to protect that patient/doctor relationship and make cer do exactly what it's supposed to, do and it has atremendously important mission, we ought to at least put this patient's bill in here to protect us so we won't have that kind of problem i experienced with mr. weems who did the best job he can probably try to do. it's just that we have folks

over there that have some pretty crazy ideas. you know, when they come and visit with you, mr. chairman, they bring a lot of staff. one staff member indicated. well, one way we can cut costs -- i was asking them other ways to cut costs rather than cost containment in regards to how it works today. and he said by age. i said oh, by age. senator mikulski, your better listen to this. i used a fig are that was below both of us. i used a figure that was below both of us. what about these folks. should they get a knee replacement, hip replacement and that person said well maybe not. now that sounds like that can't happen in the system we're trying to construct today, but i'm telling you, it can. that's why i've introduced the bill. i've gone on way to long. i appreciate the patience and indulgence of my colleague.

>> thank you, senator. senator mikulski. >> first of all, let me just say that this amendment offered by the senator from kansas is unnecessary. if you go -- because we get into this cost. we get into this repetitive word and it goes over very well with focus groups, but it has no rationale here. if you go to page 323 of the actual bill, where it says incorporation, we absolutely prohibit that this -- anything related to the center for health outcomes, otherwise known as comparative effectiveness, that there shall not be construed as mandates for payment, coverage

or treatment. it is in the bill. page 323, lines five through seven. so, please, take a look at it. if in some way that's wrong, tell me about that. but we absolutely say it shall not be construed as mandates for payment, coverage or treatment. it builds on the language that was passed in the american recovery act in which we established a counsel and funded it to do comparative effectiveness research where we say nothing in this section shall be construed to permit the counsel to mandate coverage reimbursement or any other policies for any public or private payer. it also goes that far. it says none of the reports submitted under this section or recommendation shall be construed as mandates or

clinical guidelines for payment, coverage or treatment. so we don't go to the doctor/patient relationship. and, in fact, when senator roberts and i were working on the issue of terrorism and also on the issue of first responders, senator roberts very aptly always said who is in charge? and it was the local sheriff while we were funding other programs. who is in charge in the doctors' office? the doctor. with shared responsibility to the patient. the patient must be involved. but there is no government agency that is going to dictate how to practice medicine coming out of this bill. it is a myth. it is a fabrication or it is a misunderstanding of the language. if any way the actual language is fought, then i welcome that

analysis and insight as senator ensi point out we can sharpen our language in the six or seven amendments that i accepted from him which were actual improvements on what we wanted to do and set clear and sharper, more defined parameters. so what the senator from kansas wants to do is not needed. the second thing in terms of sharing this and its appropriate dissemination, which is in the other part of his bill, we do it. so let me just say this. our provisions are designed to compare drugs, devices and other procedures. it's research and disseminate scientific evidence about what works best in certain circumstances. but at least the final decision

up to the doct-- in all of our provision, we never use the word cost when describing centers, duty, power, research or dissemination activities. it simply provides news that you can use. so i appreciate the comments by the senator from kansas, but i think that this is an unnecessary amendment and i think it ought to be just defeated or withdrawn. >> what i got is that the council can use it that way but can cms use that -- >> if you go to page 23 -- excuse me, 323, and, senator iinvite you and your staff to look at that because, again if we've got gaps or so on in the language, i would welcome that.

>> when you have the has of cms not even realizing that what he promised was not put into effect and when you have rationing today. don't tell me we don't have rationing today because i know of many, many doctors who are now not serving medicare patients or providing medicare because they do not feel the payment back to them even resembles anything close to cost, plus all the paperwork, plus everything else. and the more and more you see that, and i will tell you what happened to the competitive bidding thing. we delayed that for 18 months, thank goodness, but the 24

providers in regards to home health care who did get the competitive bid and had to start all over again, and i know of several of them who said the heck with it. and they aren't serving medicare patients. i don't know about medicaid. that's a whole different matter. but the whole point is i know that you have in here on 3/23 the federal and private health care reports and recommendations shall not be construed as mandates for payments, coverage and payment. but there's nothing in here that doesn't say cms can't use it. and i can tell you -- i tell you, senator. i love you. i love you to death. >> well, you are killing me. >> i loved you on the intelligence committee and the whole business. we've always worked together. but beware the ides of cms. once they get ahoefld this golden tablet of cer coming down from mt. health and human services, they will grab that

thing like a dog with a bone. and it's going to be -- it's going to be basically a blueprint for rationing health care. maybe i'm wrong. maybe i have just been through all of these experiences and think that there's, you know, things there that aren't there. i don't think so. and i don't see any problem if it is duplicative. where has it been said that congress can't be duplicative in trying to protect patient's choice. i appreciate the comments from my friend from maryland. >> all right. no further debate on the amendment. all those in favor of the -- >> i'd like a roll call vote. >> the clerk will call the roll. >> senator dodd? >> no. >> senator -- >> no, by proxy. >> senator mikulski. >> no.

>> senator bingaman. >> no, by proex. >> senator murray. >> no, by proxy. >> senator reed. >> no. >> senator sanders. >> no. >> senator brown. >> -- >> senator casey. >> no. >> senator higgens. >> no, by proxy. >> senator murphy. >> no. >> senator whitehouse. >> no. >> senator enzi? >> aye. >> senator greg. >> aye by proxy. >> senator alexander. >> aye by proxy. >> senator burress. >> aye by proxy. >> senator mccain? >> aye by proxy. >> senator mikowski. >> aye by proxy. >> senator roberts. >> aye. >> chairman kennedy. >> no, by proxy. >> the ayes are 10, nays are 15. i thank our colleagues. are there further amendments to title two? >> i think senator coburn.

>> tom? >> could i inquire. senator mikulski was very straightforward and honest about what was really intended in the cer stuff. and when she was asked by senator greg in our kind of roundtable about what their intention were to really tell a difference between, you know, i just have some questions so i can understand. i think we use -- i can't remember the examples. maybe it was claritin and allegra. i think he used one of the other. let's say cer comes out and says one is better than the other. what's going to be the require me ment? what's going to be the requirement for somebody who is practicing medicine and allegra doesn't work for their patient but claritin does? >> the doctor -- excuse me pooim

sorry. the doctor decides what the concurrence of the patient. >> so does he have to document that he didn't follow cer guidelines? >> i'm not sure what the rules and regs would be. that would be part of what the secretary puts together. >> that's my whole problem with this is what's the secretary put together? the fact -- i have an amendment, coburn number 9, that i'd like -- >> coburn number 9. >> let's go to coburn number 9. >> we ask the clerk to distribute that. >> tom, you got copies of that? >> thanks very much.

mr. chairman, some of the conversations that we've had, especially during the roundtable was the fact that the cer section was to provide research but to not necessarily mandate standards or deny care. and if you go to section 1013 of the medicare modernization act, which passed congress with bipartisan support, and you look at that, there shouldn't be any reason to oppose this amendment. and what this amendment is

designed to do and what the medicare modernization act was designed to do was to not allow somebody besides you and your physician to decide what your care is going to be. and as senator mikulski has directly noted, i can give you a million examples why cer isn't going to work. and if we think it's going to work, for any other reason other than to ultimately practice medicine at the federal government or use it as a tool to ration, one of the ways to secure that it's not going to be that is to adopt this amendment and embracing what happened in 2003 in the medicare modernization act. what this amendment would require that the director of the center for comparative effectiveness research shall not mandate any national standards of clinical practice. mandate. doesn't mean they can't study and recommend. but it means they won't mandate

it. and the reason that's important is as a question i raised when we were having the conversation because if you mandate it and then my patient, using the art of medicine as well as clinical experience, shouldn't be treated that way, you have created liability for me that will be impossible for me to defend in the court of law because the government says this is the way you treat patients, not what my clinical experience and the art of medicine as well as the science of medicine. the second thing it does is it prohibits cms from making any conversation decisions bases on this information. that's the current law. shall include a reference to the aboved prohibition and any recommendation to ult are from projects funded and published by the director and any research, evaluation, communication, activities performed must reflect the principle that clinicians, doctors and providers and their patients should have the best available

evidence upon which to make the choices in health care. items and services, drugs, treatments, devices. but that it is -- research must recognize that patients sub populations and patient physician preferences may vary. all given the same outcome. and so if we have the assurance that this isn't meant to rationing care, and that our purpose in doing this is to find out what we think is best most of the time for the average patient and we want to put that out, then fine. but if we're going to tell doctors what they're going to do and patients what they're going to do, it isn't fine. because it's not based on the best care. it's based on the best -- the average based on cost as well as outcome. so without this amendment, i would like to know what section of the bill prohibits the

government from using cer to decide what treatments the patients can and captain have. what section of the bill prohibits the government from using cer to deny medicare benefits to patients because they're elderly, frail or too expensive for the government to keep alive. what section of the bill prohibits the government from rationing methodologies like they use in england under n.i.c.e. i trust that your intent is good. but where's the protection? and i will go back and remind you today, a medicare patient kchbt -- even with their own money -- have a virtual colonoscopy. per orders of the dictate of cms. and so cms has decided that's too expensive for the benefits that we get. so now no medicare patient can have it. and we're already starting to see inside